The purpose of this study is to investigate whether neratinib can further reduce the risk of recurrence from previously diagnosed HER-2 positive breast cancer after adjuvant treatment with trastuzumab.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
2,840
Invasive Disease-free Survival (iDFS) in Neratinib Arm Compared to Placebo Arm at Year 2
Invasive disease-free survival time is defined as the time from date of randomization until the first disease recurrence of the following events: invasive ipsilateral breast tumor recurrence, invasive contralateral breast cancer, local/regional invasive recurrence, distant recurrence and death from any cause.
Time frame: From randomization until time of event up to 2 years
Kaplan-Meier Estimates of Invasive Disease-free Survival (iDFS) at Year 2 by Treatment Arms
Time frame: From randomization until time of event up to 2 years
Overall Survival (OS)
OS was defined as the time from randomization to death due to any cause, censored at the last date known alive.
Time frame: Randomization until death due to any cause (up to 119 Months)
Disease-free Survival Including Ductal Carcinoma in Situ (DFS-DCIS) in Neratinib Arm Compared to Placebo Arm at Year 2
Disease-free survival including DCIS time is defined as the time from date of randomization until the first occurrence of DCIS or an iDFS event (an iDFS event including invasive ipsilateral breast tumor recurrence, invasive contralateral breast cancer, local/regional invasive recurrence, or distant recurrence and death from any.
Time frame: From randomization until time of event up to 2 years
Kaplan-Meier Estimates of Disease-free Survival Including Ductal Carcinoma in Situ (DFS-DCIS) at Year 2 by Treatment Arms
Time frame: From randomization until time of event up to 2 years
Distant Disease-free Survival (DDFS) in Neratinib Arm Compared to Placebo Arm at Year 2
Distant disease-free survival time is defined as the time from date of randomization until the first occurrence of distant recurrence or death from any cause.
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Anniston Oncology
Anniston, Alabama, United States
Birmingham Hematology and Oncology Associates, LLC
Birmingham, Alabama, United States
Arizona Oncology Associates, PC - HAL
Phoenix, Arizona, United States
Arizona Oncology Associates, PC - NAHOA
Sedona, Arizona, United States
Arizona Oncology Associates
Tucson, Arizona, United States
Arizona Cancer Center
Tucson, Arizona, United States
Northeast Arkansas Clinic
Jonesboro, Arkansas, United States
Cedars-Sinai Medical Group
Beverly Hills, California, United States
Ronald Yanagihara, M.D.
Gilroy, California, United States
Glendale Adventist Medical Center Cancer Services
Glendale, California, United States
...and 484 more locations
Time frame: From randomization until time of event up to 2 years
Kaplan-Meier Estimates of Distant Disease-free Survival (DDFS) at Year 2 by Treatment Arms
Time frame: From randomization until time of event up to 2 years
Percentage of Participants With Time to Distant Recurrence (TTDR) Event in Neratinib Arm Compared to Placebo Arm at Year 2
Percentage of Participants with TTDR events is reported. TTDR is defined as the time from date of randomization until the first occurrence of distant recurrence or death from breast cancer.
Time frame: From randomization until time of event up to 2 years
Kaplan-Meier Estimates of Time to Distant Recurrence (TTDR) Survival at Year 2 by Treatment Arms
Time frame: From randomization until time of event up to 2 years
Central Nervous System Recurrence in Neratinib Arm Compared to Placebo Arm at Year 2
CNS recurrence is defined as the time from randomization to CNS as the first distant recurrence. Competing events include distant recurrence at other sites as the first distant recurrence and death from any cause prior to distant recurrence.
Time frame: From randomization until time of event up to 2 years
Cumulative Incidence of Central Nervous System Recurrence (CNS) at Year 2
Cumulative incidence of Central Nervous System Recurrence (CNS) is estimated by Gray's method (Gray,1988).
Time frame: From randomization until time of event up to 2 years